Actively Recruiting

Phase Not Applicable
Age: 45Years - 80Years
All Genders
NCT04144907

Protein Needs Study

Led by University of Alberta · Updated on 2026-05-12

40

Participants Needed

1

Research Sites

492 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Severe muscle loss in patients with cancer has been associated with increased physical disability, extended hospitalization, infectious and noninfectious complications, increased risk of severe toxicity during cancer treatment, poor quality of life and shortened survival. Adequate protein is key to sustain muscle mass and overall health. However, current nutritional recommendations are not specific or evidence-based. The aim of this project is to determine the protein needs of patients with colorectal or breast cancer. Protein needs will be determined using a novel, non-invasive approach. Our results will inform nutritional recommendations and guidelines with the ultimate goal of improving outcomes for people with cancer.

CONDITIONS

Official Title

Protein Needs Study

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Outpatients aged 45 to 80 years
  • Diagnosed with colorectal or breast cancer, stages II to III
  • Attending the new patient clinic at the Cross Cancer Institute
  • Able to complete baseline visits within about 4 weeks of starting chemotherapy or after at least 4 weeks post-surgery if not having chemotherapy
  • Ambulatory and able to move independently
Not Eligible

You will not qualify if you...

  • Premenopausal women
  • Received anti-cancer hormone treatment or immunotherapy within 4 weeks before the first baseline visit
  • Renal impairment with creatinine clearance (eGFR) below 60 mL/min
  • Abnormal glucose metabolism with fasting glucose over 6 mmol/L or HbA1c over 5.7%, or as reviewed by the study team
  • Comorbidities or medications interfering with study participation or data quality (e.g., diabetes, severe obesity, hormone therapy, another active cancer)
  • Unable or unwilling to provide urine, breath, and blood samples (e.g., oxygen tank, catheter)
  • Unable to eat study meals (e.g., receiving parenteral or enteral nutrition, severe allergies)
  • Substance dependence (e.g., alcohol, cigarettes, illicit drugs) affecting ability to follow study protocols

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Alberta

Edmonton, Alberta, Canada, T6G 2R3

Actively Recruiting

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Research Team

A

Anne Caretero, RD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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